9
Oct
2024
Watch
Urgent need to revise the Medical Devices Regulation (debate)
Mr President, Commissioner, ladies and gentlemen, why this debate? Because a large number of the groups in this Parliament feel that there is an urgent need to review the regulation of medical devices. I, Commissioner, give you just one piece of information to understand a rule that is not working and is causing delays: 15 900 applications for new medical devices were filed at the European Patent Office in 2023, one every 30 minutes. And there is still today, in the current regulation, the risk that the procedure must be repeated for many of the devices that today are placed in the health system of all the states of the European Union. What is the result? The result is that, for example, paediatric patients are at great risk of missing devices for cardiovascular diseases and there is a very strong feeling that excessively bureaucratic legislation is also distancing the production of devices from the European Union. Then it is time to make a reflection, to do it quickly. And well said, I conclude immediately, the Commissioner, that we need a greater investment in EU4Health. It is a pity, however, that this investment has failed precisely in the budgetary perspective.